80_FR_65894 80 FR 65687 - Syngenta Seeds Inc.; Availability of Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Glyphosate and Glufosinate-Ammonium Resistance

80 FR 65687 - Syngenta Seeds Inc.; Availability of Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Glyphosate and Glufosinate-Ammonium Resistance

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 207 (October 27, 2015)

Page Range65687-65689
FR Document2015-27296

We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of corn events Bayer/Genective S.A.VCO-01981-5 (hereinafter Genective VCO-01981-5 corn) and Pioneer's DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event MZHG0JG in response to a request from Syngenta Seeds Inc. MZHG0JG corn has been genetically engineered for resistance to the herbicide glyphosate using the same mechanism of action as Genective VCO-01981-5 and also to be resistant to the herbicide glufosinate using the same mechanism of action as Pioneer 4114. We are making available for public comment our preliminary finding of no significant impact for the proposed determination of nonregulated status.

Federal Register, Volume 80 Issue 207 (Tuesday, October 27, 2015)
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65687-65689]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27296]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

========================================================================


Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / 
Notices

[[Page 65687]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0080]


Syngenta Seeds Inc.; Availability of Preliminary Finding of No 
Significant Impact and Preliminary Decision for an Extension of a 
Determination of Nonregulated Status of Corn Genetically Engineered for 
Glyphosate and Glufosinate-Ammonium Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has reached a preliminary decision to extend our 
determination of nonregulated status of corn events Bayer/Genective 
S.A.VCO-01981-5 (hereinafter Genective VCO-01981-5 corn) and Pioneer's 
DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event 
MZHG0JG in response to a request from Syngenta Seeds Inc. MZHG0JG corn 
has been genetically engineered for resistance to the herbicide 
glyphosate using the same mechanism of action as Genective VCO-01981-5 
and also to be resistant to the herbicide glufosinate using the same 
mechanism of action as Pioneer 4114. We are making available for public 
comment our preliminary finding of no significant impact for the 
proposed determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
November 27, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0080.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0080, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    The Syngenta Seeds Inc. extension request, our preliminary finding 
of no significant impact, our preliminary determination, and any 
comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0080 or in our reading 
room, which is located in Room 1141 of the USDA South Building, 14th 
Street and Independence Avenue SW., Washington, DC. Normal reading room 
hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. 
To be sure someone is there to help you, please call (202) 799-7039 
before coming.
    Supporting documents and any comments we received regarding our 
determination of nonregulated status of the antecedent organisms, 
Genective VCO-01981-5 corn and Pioneer 4114 corn, can be found at 
http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0046 and http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0026. Supporting 
documents may also be found on the APHIS Web site for MZHG0JG corn (the 
organism under evaluation) under APHIS Petition Number 15-124-01p, and 
the antecedent organisms Genective VCO-01981-5 corn and Pioneer 4114 
corn under APHIS Petition Numbers 11-342-01p and 11-244-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 20737-1236; 
(301) 851-3954, email: [email protected]. To obtain copies 
of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, 
email: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (PPA) (7 U.S.C. 7701 et seq.), 
the regulations in 7 CFR part 340, ``Introduction of Organisms and 
Products Altered or Produced Through Genetic Engineering Which Are 
Plant Pests or Which There Is Reason to Believe Are Plant Pests,'' 
regulate, among other things, the introduction (importation, interstate 
movement, or release into the environment) of organisms and products 
altered or produced through genetic engineering that are plant pests or 
that there is reason to believe are plant pests. Such genetically 
engineered organisms (GE) and products are considered ``regulated 
articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.
    On September 25, 2013,\1\ APHIS announced its determination of 
nonregulated status of corn (Zea mays) designated as event VCO-01981-5 
(hereinafter Genective VCO-01981-5 corn), which was genetically 
engineered for resistance to the herbicide glyphosate. On June 20, 
2013,\2\ APHIS announced its determination of nonregulated status of 
corn designated as event DP-004114-3 (hereinafter Pioneer 4114 corn), 
which was genetically engineered for resistance to the herbicide 
glufosinate-ammonium. APHIS has received a request for an extension of 
a determination of nonregulated status of Genective VCO-01981-5 corn 
and Pioneer 4114 corn to corn designated as event MZHG0JG (APHIS 
Petition Number 15-124-01p) from Syngenta Seeds Inc. (Syngenta) of 
Research Triangle Park, NC. MZHG0JG corn expresses resistance to both 
glyphosate and glufosinate-ammonium. In its request, Syngenta stated 
that this corn is similar to the antecedent organisms, Genective VCO-
01981-5 corn and Pioneer 4114 corn and, based on the similarity to 
these antecedent organisms, is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
---------------------------------------------------------------------------

    \1\ https://www.aphis.usda.gov/brs/aphisdocs/11_34201p_det.pdf.
    \2\ https://www.aphis.usda.gov/brs/aphisdocs/11_24401p_det.pdf.
---------------------------------------------------------------------------

    As described in the extension request, MZHG0JG corn was developed 
through agrobacterium-mediated transformation to stably incorporate the 
transgenes

[[Page 65688]]

mepsps-02 and pat-09 into the MZHG0JG corn genome. The gene mepsps-02 
encodes the enzyme modified 5-enol pyruvylshikimate-3-phosphate 
synthase (mEPSPS), a variant of the native EPSPS enzyme from corn, 
which contains two amino acid substitutions that were introduced 
specifically to confer resistance to herbicides containing glyphosate. 
The gene pat-09 encodes the enzyme phosphinothricin acetyltransferase 
(PAT) derived from the soil bacterium Streptomyces viridochromogenes. 
PAT acetylates glufosinate-ammonium, thus inactivating it and 
conferring resistance to glufosinate-ammonium in herbicide products. 
The antecedent organisms, Genective VCO-01981-5 corn and Pioneer 4114 
corn, were similarly genetically engineered to produce proteins which 
catalyze the same reactions as do the proteins produced in MZHG0JG 
corn. Based on the information in the request, we have concluded that 
MZHG0JG corn is similar to Genective VCO-01981-5 corn and Pioneer 4114 
corn. MZHG0JG corn is currently regulated under 7 CFR part 340.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS evaluates the plant pest risk of the article. 
In section 403 of the PPA, ``plant pest'' is defined as any living 
stage of any of the following that can directly or indirectly injure, 
cause damage to, or cause disease in any plant product: A protozoan, a 
nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or 
viroid, an infectious agent or other pathogen, or any article similar 
to or allied with any of the foregoing.
    APHIS completed plant pest risk assessments (PPRA) on the 
antecedent organisms in which we concluded that Genective VCO-01981-5 
corn and Pioneer 4114 corn are unlikely to present plant pest risks. 
APHIS also prepared a plant pest risk similarity assessment (PPRSA) to 
compare MZHG0JG to the antecedents. As described in the PPRSA, the 
proteins expressed in MZHG0JG corn are similar to those expressed in 
Genective VCO-01981-5 corn and Pioneer 4114 corn, and APHIS has 
concluded that the proteins expressed in Genective VCO-01981-5 corn and 
Pioneer 4114 corn are unlikely to affect the plant pest risk of 
Genective VCO-01981-5 corn and Pioneer 4114 corn. Furthermore, the 
Environmental Protection Agency reviewed the safety of the proteins 
expressed in MZHG0JG corn and concluded that adverse effects will not 
occur to nontarget organisms. Therefore, based on our PPRAs for 
Genective VCO-01981-5 corn and Pioneer 4114 corn and the similarity 
between Genective VCO-01981-5 corn, Pioneer 4114 corn, and MZHG0JG corn 
as described in the PPRSA, APHIS has concluded that the proteins 
expressed in MZHG0JG corn are unlikely to pose a plant pest risk and 
that MZHG0JG corn is unlikely to pose a different plant pest risk than 
Genective VCO-01981-5 corn and Pioneer 4114 corn.
    APHIS also prepared an environmental assessment (EA) for MZHG0JG 
corn based on our analysis of data submitted by Syngenta, a review of 
other scientific data, and field tests conducted under APHIS oversight. 
The EA was prepared to provide the APHIS decisionmaker with a review 
and analysis of any potential environmental impacts associated with the 
determination of nonregulated status for MZHG0JG corn. The EA was 
prepared in accordance with: (1) The National Environmental Policy Act 
of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.); (2) regulations of 
the Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508); (3) USDA regulations 
implementing NEPA (7 CFR part 1b); and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    In addition, APHIS has carefully examined the existing NEPA 
documentation completed for Genective VCO-01981-5 corn and Pioneer 4114 
corn and has concluded that Syngenta's request to extend a 
determination of nonregulated status to MZHG0JG corn encompasses the 
same scope of environmental analysis as Genective VCO-01981-5 corn and 
Pioneer 4114 corn. Therefore, based on the similarity of MZHG0JG corn 
to Genective VCO-01981-5 corn and Pioneer 4114 corn, APHIS has prepared 
a preliminary finding of no significant impact (FONSI) on MZHG0JG corn. 
APHIS is considering the following alternatives: (1) Take no action, 
i.e., APHIS would not change the regulatory status of MZHG0JG corn and 
it would continue to be a regulated article, or (2) make a 
determination of nonregulated status of MZHG0JG corn. APHIS' preferred 
alternative is to make a determination of nonregulated status of 
MZHG0JG corn.
    APHIS has analyzed information submitted by Syngenta, references 
provided in the extension request, peer-reviewed publications, and 
information in the EAs of the antecedent organisms. APHIS has also 
analyzed information in the PPRAs for the antecedent organisms, and 
other information. Based on APHIS' analysis of this information, the 
similarity of MZHG0JG corn to the antecedent organisms, our conclusion 
that the proteins expressed in MZHG0JG corn are unlikely to pose a 
plant pest risk, and our conclusion that MZHG0JG corn is unlikely to 
pose a different plant pest risk than Genective VCO-01981-5 corn and 
Pioneer 4114 corn, APHIS has determined that MZHG0JG corn is unlikely 
to pose a plant pest risk. We have therefore reached a preliminary 
decision to approve the request to extend the determination of 
nonregulated status of Genective VCO-01981-5 corn and Pioneer 4114 corn 
to MZHG0JG corn, whereby MZHG0JG corn would no longer be subject to our 
regulations governing the introduction of certain genetically 
engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of Genective VCO-01981-5 corn and Pioneer 4114 corn to MZHG0JG 
corn.
    APHIS will accept written comments on the preliminary FONSI 
regarding a determination of nonregulated status of MZHG0JG corn for a 
period of 30 days from the date this notice is published in the Federal 
Register. The preliminary FONSI, as well as the extension request, 
supporting documents, and our preliminary determination with appended 
PPRSA for MZHG0JG corn, are available for public review as indicated 
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of 
these documents may also be obtained by contacting the person listed 
under FOR FURTHER INFORMATION CONTACT.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments will be available for public review. After 
reviewing and evaluating the comments, if APHIS determines that no 
substantive information has been received that would warrant APHIS 
altering its preliminary regulatory determination or FONSI, our 
preliminary regulatory determination will become final and effective 
upon notification of the public through an announcement on our Web site 
at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml. APHIS will also furnish a response to 
the petitioner regarding

[[Page 65689]]

our final regulatory determination. No further Federal Register notice 
will be published announcing the final regulatory determination 
regarding MZHG0JG corn.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 22nd day of October.
Michael C. Gregoire,
Associate Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-27296 Filed 10-26-15; 8:45 am]
BILLING CODE 3410-34-P



                                                                                                                                                                                                    65687

                                              Notices                                                                                                       Federal Register
                                                                                                                                                            Vol. 80, No. 207

                                                                                                                                                            Tuesday, October 27, 2015



                                              This section of the FEDERAL REGISTER                    APHIS–2015–0080, Regulatory Analysis                  environment) of organisms and products
                                              contains documents other than rules or                  and Development, PPD, APHIS, Station                  altered or produced through genetic
                                              proposed rules that are applicable to the               3A–03.8, 4700 River Road, Unit 118,                   engineering that are plant pests or that
                                              public. Notices of hearings and investigations,         Riverdale, MD 20737–1238.                             there is reason to believe are plant pests.
                                              committee meetings, agency decisions and                  The Syngenta Seeds Inc. extension                   Such genetically engineered organisms
                                              rulings, delegations of authority, filing of            request, our preliminary finding of no                (GE) and products are considered
                                              petitions and applications and agency
                                              statements of organization and functions are
                                                                                                      significant impact, our preliminary                   ‘‘regulated articles.’’
                                              examples of documents appearing in this                 determination, and any comments we                       The regulations in § 340.6(a) provide
                                              section.                                                receive on this docket may be viewed at               that any person may submit a petition
                                                                                                      http://www.regulations.gov/                           to the Animal and Plant Health
                                                                                                      #!docketDetail;D=APHIS-2015-0080 or                   Inspection Service (APHIS) seeking a
                                              DEPARTMENT OF AGRICULTURE                               in our reading room, which is located in              determination that an article should not
                                                                                                      Room 1141 of the USDA South                           be regulated under 7 CFR part 340.
                                              Animal and Plant Health Inspection                      Building, 14th Street and Independence                Further, the regulations in § 340.6(e)(2)
                                              Service                                                 Avenue SW., Washington, DC. Normal                    provide that a person may request that
                                              [Docket No. APHIS–2015–0080]
                                                                                                      reading room hours are 8 a.m. to 4:30                 APHIS extend a determination of
                                                                                                      p.m., Monday through Friday, except                   nonregulated status to other organisms.
                                              Syngenta Seeds Inc.; Availability of                    holidays. To be sure someone is there to              Such a request must include
                                              Preliminary Finding of No Significant                   help you, please call (202) 799–7039                  information to establish the similarity of
                                              Impact and Preliminary Decision for an                  before coming.                                        the antecedent organism and the
                                              Extension of a Determination of                           Supporting documents and any                        regulated article in question.
                                              Nonregulated Status of Corn                             comments we received regarding our                       On September 25, 2013,1 APHIS
                                              Genetically Engineered for Glyphosate                   determination of nonregulated status of               announced its determination of
                                              and Glufosinate-Ammonium                                the antecedent organisms, Genective                   nonregulated status of corn (Zea mays)
                                              Resistance                                              VCO–01981–5 corn and Pioneer 4114                     designated as event VCO–01981–5
                                                                                                      corn, can be found at http://                         (hereinafter Genective VCO–01981–5
                                              AGENCY:  Animal and Plant Health                        www.regulations.gov/                                  corn), which was genetically engineered
                                              Inspection Service, USDA.                               #!docketDetail;D=APHIS-2012-0046 and                  for resistance to the herbicide
                                              ACTION: Notice.                                         http://www.regulations.gov/                           glyphosate. On June 20, 2013,2 APHIS
                                                                                                      #!docketDetail;D=APHIS-2012-0026.                     announced its determination of
                                              SUMMARY:   We are advising the public                   Supporting documents may also be                      nonregulated status of corn designated
                                              that the Animal and Plant Health                        found on the APHIS Web site for                       as event DP–004114–3 (hereinafter
                                              Inspection Service has reached a                        MZHG0JG corn (the organism under                      Pioneer 4114 corn), which was
                                              preliminary decision to extend our                      evaluation) under APHIS Petition                      genetically engineered for resistance to
                                              determination of nonregulated status of                 Number 15–124–01p, and the                            the herbicide glufosinate-ammonium.
                                              corn events Bayer/Genective S.A.VCO–                    antecedent organisms Genective VCO–                   APHIS has received a request for an
                                              01981–5 (hereinafter Genective VCO–                     01981–5 corn and Pioneer 4114 corn                    extension of a determination of
                                              01981–5 corn) and Pioneer’s DP–                         under APHIS Petition Numbers 11–342–                  nonregulated status of Genective VCO–
                                              004114–3 (hereinafter Pioneer 4114
                                                                                                      01p and 11–244–01p.                                   01981–5 corn and Pioneer 4114 corn to
                                              corn) to Syngenta’s corn event
                                                                                                      FOR FURTHER INFORMATION CONTACT: Dr.                  corn designated as event MZHG0JG
                                              MZHG0JG in response to a request from
                                              Syngenta Seeds Inc. MZHG0JG corn has                    John Turner, Director, Environmental                  (APHIS Petition Number 15–124–01p)
                                              been genetically engineered for                         Risk Analysis Programs, Biotechnology                 from Syngenta Seeds Inc. (Syngenta) of
                                              resistance to the herbicide glyphosate                  Regulatory Services, APHIS, 4700 River                Research Triangle Park, NC. MZHG0JG
                                              using the same mechanism of action as                   Road Unit 147 Riverdale, MD 20737–                    corn expresses resistance to both
                                              Genective VCO–01981–5 and also to be                    1236; (301) 851–3954, email:                          glyphosate and glufosinate-ammonium.
                                              resistant to the herbicide glufosinate                  john.t.turner@aphis.usda.gov. To obtain               In its request, Syngenta stated that this
                                              using the same mechanism of action as                   copies of the supporting documents,                   corn is similar to the antecedent
                                              Pioneer 4114. We are making available                   contact Ms. Cindy Eck at (301) 851–                   organisms, Genective VCO–01981–5
                                              for public comment our preliminary                      3885, email: cynthia.a.eck@                           corn and Pioneer 4114 corn and, based
                                              finding of no significant impact for the                aphis.usda.gov.                                       on the similarity to these antecedent
                                              proposed determination of nonregulated                  SUPPLEMENTARY INFORMATION: Under the                  organisms, is unlikely to pose a plant
                                              status.                                                 authority of the plant pest provisions of             pest risk and, therefore, should not be
                                                                                                      the Plant Protection Act (PPA) (7 U.S.C.              a regulated article under APHIS’
                                              DATES: We will consider all comments
                                              that we receive on or before November                   7701 et seq.), the regulations in 7 CFR               regulations in 7 CFR part 340.
                                                                                                                                                               As described in the extension request,
                                              27, 2015.                                               part 340, ‘‘Introduction of Organisms
                                                                                                                                                            MZHG0JG corn was developed through
tkelley on DSK3SPTVN1PROD with NOTICES




                                              ADDRESSES: You may submit comments                      and Products Altered or Produced
                                                                                                                                                            agrobacterium-mediated transformation
                                              by either of the following methods:                     Through Genetic Engineering Which
                                                                                                                                                            to stably incorporate the transgenes
                                                 • Federal eRulemaking Portal: Go to                  Are Plant Pests or Which There Is
                                              http://www.regulations.gov/                             Reason to Believe Are Plant Pests,’’                    1 https://www.aphis.usda.gov/brs/aphisdocs/11_
                                              #!docketDetail;D=APHIS-2015-0080.                       regulate, among other things, the                     34201p_det.pdf.
                                                 • Postal Mail/Commercial Delivery:                   introduction (importation, interstate                   2 https://www.aphis.usda.gov/brs/aphisdocs/11_

                                              Send your comment to Docket No.                         movement, or release into the                         24401p_det.pdf.



                                         VerDate Sep<11>2014   19:58 Oct 26, 2015   Jkt 238001   PO 00000   Frm 00001   Fmt 4703   Sfmt 4703   E:\FR\FM\27OCN1.SGM   27OCN1


                                              65688                        Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices

                                              mepsps-02 and pat-09 into the                           01981–5 corn and Pioneer 4114 corn                    antecedent organisms, our conclusion
                                              MZHG0JG corn genome. The gene                           and the similarity between Genective                  that the proteins expressed in MZHG0JG
                                              mepsps-02 encodes the enzyme                            VCO–01981–5 corn, Pioneer 4114 corn,                  corn are unlikely to pose a plant pest
                                              modified 5-enol pyruvylshikimate-3-                     and MZHG0JG corn as described in the                  risk, and our conclusion that MZHG0JG
                                              phosphate synthase (mEPSPS), a variant                  PPRSA, APHIS has concluded that the                   corn is unlikely to pose a different plant
                                              of the native EPSPS enzyme from corn,                   proteins expressed in MZHG0JG corn                    pest risk than Genective VCO–01981–5
                                              which contains two amino acid                           are unlikely to pose a plant pest risk and            corn and Pioneer 4114 corn, APHIS has
                                              substitutions that were introduced                      that MZHG0JG corn is unlikely to pose                 determined that MZHG0JG corn is
                                              specifically to confer resistance to                    a different plant pest risk than                      unlikely to pose a plant pest risk. We
                                              herbicides containing glyphosate. The                   Genective VCO–01981–5 corn and                        have therefore reached a preliminary
                                              gene pat-09 encodes the enzyme                          Pioneer 4114 corn.                                    decision to approve the request to
                                              phosphinothricin acetyltransferase                         APHIS also prepared an                             extend the determination of
                                              (PAT) derived from the soil bacterium                   environmental assessment (EA) for                     nonregulated status of Genective VCO–
                                              Streptomyces viridochromogenes. PAT                     MZHG0JG corn based on our analysis of                 01981–5 corn and Pioneer 4114 corn to
                                              acetylates glufosinate-ammonium, thus                   data submitted by Syngenta, a review of               MZHG0JG corn, whereby MZHG0JG
                                              inactivating it and conferring resistance               other scientific data, and field tests                corn would no longer be subject to our
                                              to glufosinate-ammonium in herbicide                    conducted under APHIS oversight. The                  regulations governing the introduction
                                              products. The antecedent organisms,                     EA was prepared to provide the APHIS                  of certain genetically engineered
                                              Genective VCO–01981–5 corn and                          decisionmaker with a review and                       organisms.
                                              Pioneer 4114 corn, were similarly                       analysis of any potential environmental                  Paragraph (e) of § 340.6 provides that
                                              genetically engineered to produce                       impacts associated with the                           APHIS will publish a notice in the
                                              proteins which catalyze the same                        determination of nonregulated status for              Federal Register announcing all
                                              reactions as do the proteins produced in                MZHG0JG corn. The EA was prepared                     preliminary decisions to extend
                                              MZHG0JG corn. Based on the                              in accordance with: (1) The National                  determinations of nonregulated status
                                              information in the request, we have                     Environmental Policy Act of 1969                      for 30 days before the decisions become
                                              concluded that MZHG0JG corn is                          (NEPA), as amended (42 U.S.C. 4321 et                 final and effective. In accordance with
                                              similar to Genective VCO–01981–5 corn                   seq.); (2) regulations of the Council on              § 340.6(e) of the regulations, we are
                                              and Pioneer 4114 corn. MZHG0JG corn                     Environmental Quality for                             publishing this notice to inform the
                                              is currently regulated under 7 CFR part                 implementing the procedural provisions                public of our preliminary decision to
                                              340.                                                    of NEPA (40 CFR parts 1500–1508); (3)                 extend the determination of
                                                 As part of our decisionmaking process                USDA regulations implementing NEPA                    nonregulated status of Genective VCO–
                                              regarding a GE organism’s regulatory                    (7 CFR part 1b); and (4) APHIS’ NEPA                  01981–5 corn and Pioneer 4114 corn to
                                              status, APHIS evaluates the plant pest                  Implementing Procedures (7 CFR part                   MZHG0JG corn.
                                              risk of the article. In section 403 of the              372).                                                    APHIS will accept written comments
                                              PPA, ‘‘plant pest’’ is defined as any                      In addition, APHIS has carefully                   on the preliminary FONSI regarding a
                                              living stage of any of the following that               examined the existing NEPA                            determination of nonregulated status of
                                              can directly or indirectly injure, cause                documentation completed for Genective                 MZHG0JG corn for a period of 30 days
                                              damage to, or cause disease in any plant                VCO–01981–5 corn and Pioneer 4114                     from the date this notice is published in
                                              product: A protozoan, a nonhuman                        corn and has concluded that Syngenta’s                the Federal Register. The preliminary
                                              animal, a parasitic plant, a bacterium, a               request to extend a determination of                  FONSI, as well as the extension request,
                                              fungus, a virus or viroid, an infectious                nonregulated status to MZHG0JG corn                   supporting documents, and our
                                              agent or other pathogen, or any article                 encompasses the same scope of                         preliminary determination with
                                              similar to or allied with any of the                    environmental analysis as Genective                   appended PPRSA for MZHG0JG corn,
                                              foregoing.                                              VCO–01981–5 corn and Pioneer 4114                     are available for public review as
                                                 APHIS completed plant pest risk                      corn. Therefore, based on the similarity              indicated under ADDRESSES and FOR
                                              assessments (PPRA) on the antecedent                    of MZHG0JG corn to Genective VCO–                     FURTHER INFORMATION CONTACT above.
                                              organisms in which we concluded that                    01981–5 corn and Pioneer 4114 corn,                   Copies of these documents may also be
                                              Genective VCO–01981–5 corn and                          APHIS has prepared a preliminary                      obtained by contacting the person listed
                                              Pioneer 4114 corn are unlikely to                       finding of no significant impact (FONSI)              under FOR FURTHER INFORMATION
                                              present plant pest risks. APHIS also                    on MZHG0JG corn. APHIS is                             CONTACT.
                                              prepared a plant pest risk similarity                   considering the following alternatives:                  After the comment period closes,
                                              assessment (PPRSA) to compare                           (1) Take no action, i.e., APHIS would                 APHIS will review all written comments
                                              MZHG0JG to the antecedents. As                          not change the regulatory status of                   received during the comment period
                                              described in the PPRSA, the proteins                    MZHG0JG corn and it would continue                    and any other relevant information. All
                                              expressed in MZHG0JG corn are similar                   to be a regulated article, or (2) make a              comments will be available for public
                                              to those expressed in Genective VCO–                    determination of nonregulated status of               review. After reviewing and evaluating
                                              01981–5 corn and Pioneer 4114 corn,                     MZHG0JG corn. APHIS’ preferred                        the comments, if APHIS determines that
                                              and APHIS has concluded that the                        alternative is to make a determination of             no substantive information has been
                                              proteins expressed in Genective VCO–                    nonregulated status of MZHG0JG corn.                  received that would warrant APHIS
                                              01981–5 corn and Pioneer 4114 corn are                     APHIS has analyzed information                     altering its preliminary regulatory
                                              unlikely to affect the plant pest risk of               submitted by Syngenta, references                     determination or FONSI, our
                                              Genective VCO–01981–5 corn and                          provided in the extension request, peer-              preliminary regulatory determination
tkelley on DSK3SPTVN1PROD with NOTICES




                                              Pioneer 4114 corn. Furthermore, the                     reviewed publications, and information                will become final and effective upon
                                              Environmental Protection Agency                         in the EAs of the antecedent organisms.               notification of the public through an
                                              reviewed the safety of the proteins                     APHIS has also analyzed information in                announcement on our Web site at
                                              expressed in MZHG0JG corn and                           the PPRAs for the antecedent organisms,               http://www.aphis.usda.gov/
                                              concluded that adverse effects will not                 and other information. Based on APHIS’                biotechnology/petitions_table_
                                              occur to nontarget organisms. Therefore,                analysis of this information, the                     pending.shtml. APHIS will also furnish
                                              based on our PPRAs for Genective VCO–                   similarity of MZHG0JG corn to the                     a response to the petitioner regarding


                                         VerDate Sep<11>2014   19:58 Oct 26, 2015   Jkt 238001   PO 00000   Frm 00002   Fmt 4703   Sfmt 4703   E:\FR\FM\27OCN1.SGM   27OCN1


                                                                           Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices                                              65689

                                              our final regulatory determination. No                  holidays. To be sure someone is there to              considering petitions for determinations
                                              further Federal Register notice will be                 help you, please call (202) 799–7039                  of nonregulated status of GE organisms,
                                              published announcing the final                          before coming.                                        APHIS accepts written comments
                                              regulatory determination regarding                        Supporting documents are also                       regarding a petition once APHIS deems
                                              MZHG0JG corn.                                           available on the APHIS Web site at                    it complete. In a notice 2 published in
                                                Authority: 7 U.S.C. 7701–7772 and 7781–               http://www.aphis.usda.gov/                            the Federal Register on March 7, 2014
                                              7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and             biotechnology/petitions_table_                        (79 FR 13035–13036, Docket No.
                                              371.3.                                                  pending.shtml under APHIS Petition                    APHIS–2014–0007), APHIS announced
                                                Done in Washington, DC, this 22nd day of
                                                                                                      Number 13–290–01p.                                    the availability of the Monsanto petition
                                              October.                                                FOR FURTHER INFORMATION CONTACT: Dr.                  for public comment. APHIS solicited
                                              Michael C. Gregoire,                                    John Turner, Director, Environmental                  comments on the petition for 60 days
                                                                                                      Risk Analysis Programs, Biotechnology                 ending on May 6, 2014, in order to help
                                              Associate Administrator, Animal and Plant
                                              Health Inspection Service.                              Regulatory Services, APHIS, 4700 River                identify potential environmental and
                                                                                                      Road, Unit 147, Riverdale, MD 20737–                  interrelated economic issues and
                                              [FR Doc. 2015–27296 Filed 10–26–15; 8:45 am]
                                                                                                      1236; (301) 851–3954, email:                          impacts that APHIS may determine
                                              BILLING CODE 3410–34–P
                                                                                                      john.t.turner@aphis.usda.gov. To obtain               should be considered in our evaluation
                                                                                                      copies of the supporting documents for                of the petition.
                                              DEPARTMENT OF AGRICULTURE                               this petition, contact Ms. Cindy Eck at                  APHIS received 423 comments on the
                                                                                                      (301) 851–3892, email: cynthia.a.eck@                 petition. Issues raised during the
                                              Animal and Plant Health Inspection                      aphis.usda.gov.                                       comment period include the
                                              Service                                                                                                       contamination of conventional crop
                                                                                                      SUPPLEMENTARY INFORMATION:      The
                                                                                                                                                            production, the potential for disruption
                                              [Docket No. APHIS–2014–0007]                            regulations in 7 CFR part 340,
                                                                                                                                                            of trade due to the presence of
                                                                                                      ‘‘Introduction of Organisms and
                                                                                                                                                            unwanted genetically engineered
                                              Monsanto Co.; Determination of                          Products Altered or Produced Through
                                                                                                                                                            commodities in exports, the potential
                                              Nonregulated Status of Maize                            Genetic Engineering Which Are Plant
                                                                                                                                                            for negative impacts to plant fitness and
                                              Genetically Engineered For Protection                   Pests or Which There Is Reason to
                                                                                                                                                            the environment, and health concerns.
                                              Against Corn Rootworm and                               Believe Are Plant Pests,’’ regulate,
                                                                                                                                                            APHIS decided, based on its review of
                                              Resistance to Glyphosate                                among other things, the introduction
                                                                                                                                                            the petition and its evaluation and
                                                                                                      (importation, interstate movement, or
                                              AGENCY:  Animal and Plant Health                                                                              analysis of the comments received
                                                                                                      release into the environment) of
                                              Inspection Service, USDA.                                                                                     during the 60-day public comment
                                                                                                      organisms and products altered or
                                              ACTION: Notice.                                                                                               period on the petition, that the petition
                                                                                                      produced through genetic engineering
                                                                                                                                                            involves a GE organism that raises
                                              SUMMARY:   We are advising the public of                that are plant pests or that there is
                                                                                                                                                            substantive new issues. According to
                                              our determination that maize designated                 reason to believe are plant pests. Such
                                                                                                                                                            our public review process for such
                                              as event MON 87411, which has been                      genetically engineered (GE) organisms
                                                                                                                                                            petitions (see footnote 1), APHIS first
                                              genetically engineered for protection                   and products are considered ‘‘regulated
                                                                                                                                                            solicits written comments from the
                                              against corn rootworm and resistance to                 articles.’’
                                                                                                                                                            public on a draft environmental
                                              the herbicide glyphosate, is no longer                     The regulations in § 340.6(a) provide
                                                                                                                                                            assessment (EA) and a preliminary plant
                                              considered a regulated article under our                that any person may submit a petition
                                                                                                                                                            pest risk assessment (PPRA) for a 30-day
                                              regulations governing the introduction                  to the Animal and Plant Health
                                                                                                                                                            comment period through the
                                              of certain genetically engineered                       Inspection Service (APHIS) seeking a
                                                                                                                                                            publication of a Federal Register notice.
                                              organisms. Our determination is based                   determination that an article should not
                                                                                                                                                            Then, after reviewing and evaluating the
                                              on our evaluation of data submitted by                  be regulated under 7 CFR part 340.
                                                                                                                                                            comments on the draft EA and the
                                              Monsanto Company in its petition for a                  APHIS received a petition (APHIS
                                                                                                                                                            preliminary PPRA and other
                                              determination of nonregulated status,                   Petition Number 13–290–01p) from
                                                                                                                                                            information, APHIS revises the
                                              our analysis of available scientific data,              Monsanto Company (Monsanto) of St.
                                                                                                                                                            preliminary PPRA as necessary and
                                              and comments received from the public                   Louis, MO, seeking a determination of
                                                                                                                                                            prepares a final EA and, based on the
                                              in response to our previous notices                     nonregulated status of maize (Zea mays)
                                                                                                                                                            final EA, a National Environmental
                                              announcing the availability of the                      designated as event MON 87411, which
                                                                                                                                                            Policy Act (NEPA) decision document
                                              petition for nonregulated status and its                has been genetically engineered for
                                                                                                                                                            (either a finding of no significant impact
                                              associated environmental assessment                     protection against corn rootworm and
                                                                                                                                                            (FONSI) or a notice of intent to prepare
                                              and plant pest risk assessment. This                    resistance to the herbicide glyphosate.
                                                                                                                                                            an environmental impact statement). If
                                              notice also announces the availability of               The Monsanto petition states that
                                                                                                                                                            a FONSI is reached, APHIS furnishes a
                                              our written determination and finding                   information collected during field trials
                                                                                                                                                            response to the petitioner, either
                                              of no significant impact.                               and laboratory analyses indicates that
                                                                                                                                                            approving or denying the petition.
                                                                                                      MON 87411 maize is not likely to be a
                                              DATES: Effective October 27, 2015.                                                                            APHIS also publishes a notice in the
                                                                                                      plant pest and therefore should not be
                                              ADDRESSES: You may read the                                                                                   Federal Register announcing the
                                                                                                      a regulated article under APHIS’
                                              documents referenced in this notice and                                                                       regulatory status of the GE organism and
                                                                                                      regulations in 7 CFR part 340.
                                              the comments we received at http://                                                                           the availability of APHIS’ final EA,
                                                                                                         According to our process 1 for
                                              www.regulations.gov/                                                                                          PPRA, FONSI, and our regulatory
                                                                                                      soliciting public comment when
                                                                                                                                                            determination.
tkelley on DSK3SPTVN1PROD with NOTICES




                                              #!docketDetail;D=APHIS-2014-0007 or
                                              in our reading room, which is located in                  1 On March 6, 2012, APHIS published in the

                                              Room 1141 of the USDA South                             Federal Register (77 FR 13258–13260, Docket No.       www.regulations.gov/#!docketDetail;D=APHIS-
                                              Building, 14th Street and Independence                  APHIS–2011–0129) a notice describing our public       2011-0129.
                                                                                                      review process for soliciting public comments and       2 To view the notice, the petition, other
                                              Avenue SW., Washington, DC. Normal                      information when considering petitions for            supporting documents, and the comments we
                                              reading room hours are 8 a.m. to 4:30                   determinations of nonregulated status for GE          received, go to http://www.regulations.gov/
                                              p.m., Monday through Friday, except                     organisms. To view the notice, go to http://          #!docketDetail;D=APHIS-2014-0007.



                                         VerDate Sep<11>2014   19:58 Oct 26, 2015   Jkt 238001   PO 00000   Frm 00003   Fmt 4703   Sfmt 4703   E:\FR\FM\27OCN1.SGM   27OCN1



Document Created: 2015-12-14 15:36:02
Document Modified: 2015-12-14 15:36:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesWe will consider all comments that we receive on or before November 27, 2015.
ContactDr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected] To obtain copies of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, email: [email protected]
FR Citation80 FR 65687 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR